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OFFICE OF NEW DRUGS MODULE
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Pediatric Drug Development
Drug Evaluation in Children
Pediatric Drug Legislation
Pediatric Research Equity Act (PREA)
Best Pharmaceuticals for Children Act (BPCA)
PREA vs. BPCA
Certificate of Completion
Which of the following is not contained in the FDA adaptation of the guidelines based on the general principles of ICH E-11?
Pediatric studies present significant ethical concerns and increased liability risk for drug manufacturers.
Pediatric patients should be given medicines that have been properly evaluated for use in the pediatric population.
Product development programs should include pediatric studies when appropriate.
Pediatric product development should not delay adult studies or the availability of drugs for adult patient.
Which of the following does not apply to the Best Pharmaceuticals for Children Act?
It provides a financial incentive to pharmaceutical companies to test drugs with remaining patent life in pediatric patients.
It creates a process by which FDA and the National Institutes of Health can partner to obtain studies of off-patent drugs in pediatric patients.
It requires pharmaceutical companies to assess the safety and effectiveness of new drug and biologic products in pediatric patients.
The Pediatric Research Equity Act authorizes the FDA to require a pediatric assessment of the safety and effectiveness of a drug or biologic for the claimed indications in all relevant pediatric subpopulations.
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